Using improved data management the manufacturer solved production problems quickly, which led to improved regulatory compliance.
Background: The manufacture of pharmaceuticals is complex and drugs must be rigorously tested and quality controlled before entering the supply chain. Ensuring regulatory compliance is another important factor that complicates operations management.
The pharmaceutical company required an improved system of alerts in order to reduce time involved with taking corrective action and increasing compliance. The challenge involved data that was scattered across disparate systems. Alerts were not being generated quickly enough and even once they were generated, because the data was so disorganized, it took analysts a significant amount of time to compile all the data for analysis.
Predictum team developed an SPC system that monitored the various sources of data. The system generated alerts and informed the appropriate technician and supervisor. This email included a particular JMP script based on the production stage that generated the alert. Once the email was received, the analyst simply launched that script to draw relevant information and produce a set of pre-determined analyses. In this way, the analyst was immediately in problem solving mode – no time lost trying to figure out what was needed, getting the needed data very any number of SQL queries then joining the data together appropriately then, finally figuring out what analysis would be most helpful. The script did all of that in an instant.
When the analyst had a recommendation to resolve the problem, they needed to get approval. The emailed script facilitated this. All one had to do was click a button and another email was generated and sent to the supervisor. That email would also arrive with a script that pulled and assembled the data and recreated the analysis and reported on the recommended course of action. The supervisor could then conduct their own analysis and then approve or disapprove the recommended course of action.
Throughout this whole process of alerting, analysing and approving the system manages what we call a Compliance as a Consequence™ (CAC) database. A CAC database automatically records all data, analysis, comments-entered, approvals sought and approvals are granted and declined. Each of these events are time-stamped and all of the compliance work happens automatically – without additional effort. The benefit is that staff can remained focussed on their primary task, if they are ever audited they need only point the auditors to the compliance database.
Through a process control strategy, facilitated by an SPC system, productivity has increased, fewer mistakes are made and it is easier to investigate problems before they become excursions.
Now that the manufacturer had the new SPC in place alerts were reduced to real time and with the accelerated corrective action time to resolution was cut by 49%. Adoption of the Compliance as a Consequence™ (CAC) database provided automatic records keeping and compliance was automated, this enabled staff able to work undistracted on production with increased productivity.